The Development, Evaluation and Implementation of a Web-Based System for Generating Clinical Trials Protocols

At UBC, we have developed a learning tool named the Web-Based Clinical Trial Expert System (WebCTES), which directs students in the Health Sciences to design and implement clinical trials. The randomized controlled clinical trial is the best method for obtaining the evidence necessary for clinical decisions. Unfortunately, many clinical trials fail to provide reliable evidence because of improper design and statistical methods, a lack of concern for confounding factors, or a disregard for use of standard operating procedures. Our students need this ability to guarantee UBC’s future in health research. Presently, research training in the principles of Good Clinical Practices (GCPs) and protocol writing is mainly done through lectures and available manuals and textbooks. Unlike the existing systems, WebCTES provides a comprehensive and knowledge-based approach to problem solving. WebCTES will be evaluated through a randomized controlled experiment using the same principles of Good Clinical Practice that form the basis of the system’s knowledge base. Since the clinical research protocol is a marker of clinical trial quality, the evaluation of protocols generated by subjects provides a meaningful comparison to existing methods. The development, testing and implementation of WebCTES will enable UBC students, resident physicians, and Faculty to produce protocols needed in the rapidly growing areas of clinical research.

Bernard MacLeod, Associate Professor, Pharmacology and Therapeutics / Anaesthesia, Faculty of Medicine
Lui Franciosi, Ph.D. Student, Pharmacology and Therapeutics, Faculty of Medicine
Mihai Huzmezan, Assistant Professor, Electrical and Computer Engineering, Faculty of Applied Science
Kjeil Rubenson, Professor, Adult Education, Faculty of Education